Pilot study of a ketogenic diet in relapsing-remitting MS

To assess the safety and tolerability of a modified Atkins diet (KD^MAD), a type of ketogenic diet (KD), in subjects with relapsing MS while exploring potential benefits of KDs in MS.

Twenty subjects with relapsing MS enrolled into a 6-month, single-arm, open-label study of the KD^MAD. Adherence to KD^MAD was objectively monitored by daily urine ketone testing. Fatigue and depression scores and fasting adipokines were obtained at baseline and on diet. Brain MRI was obtained at baseline and 6 months. Intention to treat was used for primary data analysis, and a per-protocol approach was used for secondary analysis.

No subject experienced worsening disease on diet. Nineteen subjects (95%) adhered to KD^MAD for 3 months and 15 (75%) adhered for 6 months. Anthropometric improvements were noted on KD^MAD, with reductions in body mass index and total fat mass (p < 0.0001). Fatigue (p = 0.002) and depression scores (p = 0.003) were improved. Serologic leptin was significantly lower at 3 months (p < 0.0001) on diet.

KD^MAD is safe, feasible to study, and well tolerated in subjects with relapsing MS. KD^MAD improves fatigue and depression while also promoting weight loss and reducing serologic proinflammatory adipokines.

The study is rated Class IV because of the absence of a non-KD control group.